Usability engineering
We can support you with usability engineering activities, from creating a process to preparing a usability engineering file for your medical device products.
Usability engineering in medical devices
Product user experience and risk-based thinking implemented into processes are essential for the success of your medical device products. We can support you with the process creation and through the whole usability engineering process. There are several standards and guidances which partially overlap each other. Our experts can assist you with the usability engineering activities starting from creating a process in the QMS through usability risk assessment, as well as creating a usability engineering file for your device including all the necessary formative and summative tests. Application of usability engineering is mandatory for medical devices.
Usability engineering has its own standard for medical devices (IEC 62366-1), which is on the harmonization list for MDR and IVDR and is listed as a recognized consensus standard by the US FDA. This standard requires a risk-based approach and a certain set of documentation i.e., a usability engineering file. Usability engineering must be started as early as possible to understand what users need and want.
IEC 62366-1 focuses on the identification and evaluation of use-related risks and encourages user experience to be involved in the work. Also, the ISO 14971 risk management standard incorporates use-related risks and these standards overlap and cross-reference each other. IEC/TR 62366-2 provides additional guidance and explanation for 62366-1.
For medical electric devices, IEC 60601-1-6 provides additional usability considerations.
ANSI/AAMI HE75 is not recognized in the EU, but it is in the US FDA-recognized consensus standard list. This is recommended reading for anyone working with medical device usability. The US FDA provides guidance documents for medical device usability.
Our team can support you with a range of usability activities and documents, including the:
- Usability engineering process
- Full usability engineering file for medical device
- Formative test plans and reports
- Summative test plan and report
- Usability risk analysis
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